- Largest prospective clinical study to date on placental tissue allografts- Collaboration with Mölnlycke® Health Care
ROSWELL, Ga., July 18, 2024 /PRNewswire/ -- StimLabs®, a leading regenerative medicine company, announced enrollment of the first patient in CAMPSTIM, a multi-center randomized controlled trial to demonstrate the clinical outcomes of StimLabs' placental-based tissue products with standard of care (SOC) compared to SOC alone, in patients with hard-to-heal diabetic foot ulcers (DFUs). This first patient was enrolled at Tulsa Wound Center by Dr. Lam Le.
CAMPSTIM employs a novel, modified platform clinical trial design, marking the first application of such a methodology for DFUs in the US. Evaluating at least four separate StimLabs cellular, acellular, and matrix-like products (CAMPs) – Cogenex®, Revita®, Enverse®, and Relese® - the study is managed by the highly experienced SerenaGroup®, led by Thomas E. Serena, MD, FACS, FACHM, MAPWCA.
As the largest planned prospective clinical study to date on placental tissue allografts, CAMPSTIM will enroll approximately 272 patients across multiple sites in the US. The primary endpoint of the study will be the percentage of target ulcers achieving complete wound closure in 12 weeks. Secondary endpoints include time to closure, percentage of wound area reduction, number of adverse events, and changes in pain and quality of life scores.
"This trial will validate the benefits of our technologies in supporting patients' wound resolution when added to standard of care, and enrollment points to the continued progress of the study," said John Daniel, Founder and CEO of StimLabs. "The uniqueness of the CAMPSTIM trial design is recognized by the medical community, and we are pleased to work with other leaders in wound care, such as Mölnlycke® Health Care."
StimLabs has collaborated with Mölnlycke Health Care, a leader in wound care and surgical procedures, to be the exclusive wound dressing provider for CAMPSTIM. By standardizing the use of Mepilex® Border Flex, as well as the additional use of Exufiber® in highly exudating wounds, patients are treated with a consistent protocol and advanced dressings.
"We are excited to participate in this novel trial and that these patients will benefit from Mölnlycke's dressings. As a company dedicated to pioneering radical innovation, we are happy to support the validation of an approach taking standard of care to the next level with skin substitutes which will improve clinical outcomes and benefit patients," says Anders Andersson, Mölnlycke's EVP of Wound Care.
Diabetes is a well-known, often debilitating, disease affecting over 38 million people of all ages in the US.1 Each year 1-4% of these diabetic patients develop a DFU, contributing to a lifetime incidence of 10-15%.2 DFUs come with serious risks including skin and soft tissue infections, osteomyelitis, amputation, sepsis, and death.
Learn more about CAMPSTIM.
About StimLabsStimlabs LLC's mission is to advance the state of regenerative medicine, with a current focus in wound care and surgical applications. Comprised of industry leaders, StimLabs is dedicated to offering patients the best possible care while recognizing the urgency of providing solutions in areas with unmet needs. StimLabs has a comprehensive product portfolio addressing various clinical applications and has established a strong intellectual property catalog. Committed to delivering superior products, StimLabs is a trusted partner to physicians and patients alike.stimlabs.com
About MölnlyckeMölnlycke Health Care is a world-leading MedTech company that specialises in innovative solutions for wound care and surgical procedures. Mölnlycke products and solutions are used daily by hospitals, health care providers and patients in over 100 countries around the world. Founded in 1849, Mölnlycke is owned by Investor AB and headquartered in Sweden. www.molnlycke.us
1. Centers for Disease Control and Prevention. (2024, May 15). National Diabetes Statistics Report. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/php/data-research/index.html2. Margolis D, Malay DS, Hoffstad OJ, et al. Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008. Data Points #2. Rockville, MD: Agency for Healthcare Research and Quality. January 2011. AHRQ Publication No. 10(11)-EHC009-1-EF.
Patents: http://www.stimlabs.com/patents © Stimlabs® LLC; STIMLABS, Revita®, Enverse®, Relese® and Cogenex® are trademarks of Stimlabs LLC.
Media Contact:StimLabs(470) [email protected]
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ROSWELL, Ga., July 18, 2024 /PRNewswire/ -- StimLabs®, a leading regenerative medicine company, announced enrollment of the first patient in CAMPSTIM, a multi-center randomized controlled trial to demonstrate the clinical outcomes of StimLabs' placental-based tissue products with standard of care (SOC) compared to SOC alone, in patients with hard-to-heal diabetic foot ulcers (DFUs). This first patient was enrolled at Tulsa Wound Center by Dr. Lam Le.
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CAMPSTIM employs a novel, modified platform clinical trial design, marking the first application of such a methodology for DFUs in the US. Evaluating at least four separate StimLabs cellular, acellular, and matrix-like products (CAMPs) – Cogenex®, Revita®, Enverse®, and Relese® - the study is managed by the highly experienced SerenaGroup®, led by Thomas E. Serena, MD, FACS, FACHM, MAPWCA.
As the largest planned prospective clinical study to date on placental tissue allografts, CAMPSTIM will enroll approximately 272 patients across multiple sites in the US. The primary endpoint of the study will be the percentage of target ulcers achieving complete wound closure in 12 weeks. Secondary endpoints include time to closure, percentage of wound area reduction, number of adverse events, and changes in pain and quality of life scores.
"This trial will validate the benefits of our technologies in supporting patients' wound resolution when added to standard of care, and enrollment points to the continued progress of the study," said John Daniel, Founder and CEO of StimLabs. "The uniqueness of the CAMPSTIM trial design is recognized by the medical community, and we are pleased to work with other leaders in wound care, such as Mölnlycke® Health Care."
StimLabs has collaborated with Mölnlycke Health Care, a leader in wound care and surgical procedures, to be the exclusive wound dressing provider for CAMPSTIM. By standardizing the use of Mepilex® Border Flex, as well as the additional use of Exufiber® in highly exudating wounds, patients are treated with a consistent protocol and advanced dressings.
"We are excited to participate in this novel trial and that these patients will benefit from Mölnlycke's dressings. As a company dedicated to pioneering radical innovation, we are happy to support the validation of an approach taking standard of care to the next level with skin substitutes which will improve clinical outcomes and benefit patients," says Anders Andersson, Mölnlycke's EVP of Wound Care.
Diabetes is a well-known, often debilitating, disease affecting over 38 million people of all ages in the US.1 Each year 1-4% of these diabetic patients develop a DFU, contributing to a lifetime incidence of 10-15%.2 DFUs come with serious risks including skin and soft tissue infections, osteomyelitis, amputation, sepsis, and death.
Learn more about CAMPSTIM.
About StimLabsStimlabs LLC's mission is to advance the state of regenerative medicine, with a current focus in wound care and surgical applications. Comprised of industry leaders, StimLabs is dedicated to offering patients the best possible care while recognizing the urgency of providing solutions in areas with unmet needs. StimLabs has a comprehensive product portfolio addressing various clinical applications and has established a strong intellectual property catalog. Committed to delivering superior products, StimLabs is a trusted partner to physicians and patients alike.stimlabs.com
About MölnlyckeMölnlycke Health Care is a world-leading MedTech company that specialises in innovative solutions for wound care and surgical procedures. Mölnlycke products and solutions are used daily by hospitals, health care providers and patients in over 100 countries around the world. Founded in 1849, Mölnlycke is owned by Investor AB and headquartered in Sweden. www.molnlycke.us
1. Centers for Disease Control and Prevention. (2024, May 15). National Diabetes Statistics Report. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/php/data-research/index.html2. Margolis D, Malay DS, Hoffstad OJ, et al. Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008. Data Points #2. Rockville, MD: Agency for Healthcare Research and Quality. January 2011. AHRQ Publication No. 10(11)-EHC009-1-EF.
Patents: http://www.stimlabs.com/patents © Stimlabs® LLC; STIMLABS, Revita®, Enverse®, Relese® and Cogenex® are trademarks of Stimlabs LLC.
Media Contact:StimLabs(470) [email protected]
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